Dostinex

LEAFLET INCLUDED IN THE PACKAGING: PATIENT INFORMATION

WARNING! Keep the leaflet, the information on the immediate packaging is in a foreign language.

DOSTINEX, 0.5 mg, tablets
Cabergoline

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is DOSTINEX and what is it used for
• 2. Important information before taking DOSTINEX
• 3. How to take DOSTINEX
• 4. Possible side effects
• 5. How to store DOSTINEX
• 6. Contents of the pack and other information

1. What is DOSTINEX and what is it used for

DOSTINEX is an ergoline derivative with dopaminergic activity, strongly and long-lastingly lowering prolactin levels. It works by directly stimulating dopamine D2 receptors in the anterior pituitary gland cells, thereby inhibiting prolactin secretion.
DOSTINEX is indicated:

• to inhibit lactation immediately after childbirth or to stop milk production,
• to treat disorders associated with excessive prolactin secretion (hyperprolactinemia), including menstrual disorders (absence, scarcity, or irregularity), anovulation, galactorrhea,
• to treat pituitary adenoma, idiopathic hyperprolactinemia, or empty sella syndrome associated with hyperprolactinemia.

2. Important information before taking DOSTINEX

When not to take DOSTINEX

• if the patient is allergic to cabergoline or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to other ergot derivatives;
• if the patient has or has had fibrotic reactions in the heart, lungs, or abdomen;
• if the patient will be taking DOSTINEX for a long time and has currently or has had in the past fibrotic reactions (fibrosis) of the heart muscle.

Warnings and precautions

Before starting treatment with DOSTINEX, discuss it with your doctor:

• in patients with severe cardiovascular disorders,
• in patients with Raynaud's syndrome,
• in patients with peptic ulcer or gastrointestinal bleeding,
• in patients with a history of serious psychiatric disorders, particularly psychosis,
• in patients with severe liver dysfunction - a lower dose of DOSTINEX should be considered,
• in case of concomitant use of blood pressure-lowering medications, as orthostatic hypotension may occur after administration of cabergoline (especially in the first few days of treatment),
• in patients with symptoms of respiratory or cardiovascular disorders related to fibrosis or a history of such disorders,
• in patients with Parkinson's disease, sudden episodes of sleepiness may occur - the dose should be reduced or treatment discontinued,
• if the patient has currently or has had in the past fibrotic reactions (fibrosis) of the heart muscle, lungs, or abdominal organs. In patients taking DOSTINEX for a long time, the doctor will check the heart, lung, and kidney function before starting treatment. Before starting treatment and at regular intervals during treatment, echocardiographic examinations (heart ultrasound) will be performed. If fibrotic reactions occur, treatment will be discontinued,
• the patient should inform the doctor if they or their relatives notice unusual behaviors resulting from irresistible impulses, compulsions, or urges to perform certain actions that may be harmful to the patient or others. Such behaviors are called impulse control disorders and may include gambling addiction, compulsive or binge eating, excessive sexual drive, or increased sexual thoughts and feelings. The doctor may decide to adjust the treatment or discontinue the medicine. Women who have just given birth may be more susceptible to certain adverse events, including high blood pressure, heart attack, seizures, stroke, and mental disorders. Therefore, during treatment, the doctor will regularly check blood pressure. If the patient experiences high blood pressure, chest pain, or severe or persistent headache (with or without vision disturbances), they should immediately tell their doctor. The medicine should not be used in women with pregnancy-induced hypertension, pre-eclampsia, or postpartum hypertension, unless the potential benefits outweigh the risks. To avoid orthostatic hypotension, the single dose of DOSTINEX should not exceed 0.25 mg to inhibit ongoing lactation in breastfeeding women. Before starting treatment with DOSTINEX, a detailed assessment of pituitary function is recommended. Since DOSTINEX restores ovulation and fertility in women with hypogonadism associated with hyperprolactinemia, it is recommended to perform a pregnancy test at least every 4 weeks during the period before the onset of menstruation and then whenever menstrual bleeding is delayed by more than 3 days. Women who want to avoid pregnancy should use mechanical contraceptive methods during treatment with DOSTINEX and after discontinuation of the medicine until anovulation recurs. Women who become pregnant should be monitored for signs of pituitary enlargement, as pregnancy may cause the growth of pre-existing pituitary tumors. In patients treated with dopamine agonists, including cabergoline, pathological gambling, increased libido, and hypersexuality have been observed. These symptoms were usually reversible after dose reduction or discontinuation of the medicine. Consult your doctor, even if the above warnings refer to past situations.

DOSTINEX and other medicines

Tell your doctor about all the medicines you have taken recently, even those that are available without a prescription.

• There is no information on interactions between cabergoline and other ergot alkaloids, so it is not recommended to use these medicines concomitantly during long-term treatment with DOSTINEX.
• DOSTINEX should not be taken with phenothiazines, butyrophenones, thioxanthenes (antipsychotic medicines), metoclopramide (a medicine used for motility disorders of the upper gastrointestinal tract), as these medicines may reduce the therapeutic effect of DOSTINEX.
• DOSTINEX, like other ergot derivatives, should not be used concomitantly with macrolide antibiotics (e.g., erythromycin) due to increased bioavailability of cabergoline.
• DOSTINEX may cause orthostatic hypotension in patients taking antihypertensive medicines.

DOSTINEX with food and drink

Tolerance to dopaminergic medicines is better when taken with food, so it is recommended to take DOSTINEX with meals.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Before starting treatment with DOSTINEX, pregnancy should be ruled out. Additionally, measures to prevent pregnancy should be taken for at least one month after discontinuation of DOSTINEX.
There are no clinical data on the use of DOSTINEX in pregnant women. Animal studies have shown reduced fertility and possible toxicity to the fetus.
DOSTINEX should be used during pregnancy only if clearly indicated and after a careful assessment of the benefit-risk ratio.
Due to the long half-life of the medicine and limited data on fetal exposure, women planning to become pregnant should discontinue DOSTINEX one month before planned conception. If conception occurs during treatment, the treatment should be discontinued immediately after confirmation of pregnancy to minimize fetal exposure to the medicine.
Considering the mechanism of action of DOSTINEX, inhibition or reduction of lactation is expected during its use. Women taking DOSTINEX should not breastfeed.

Driving and using machines

During the initiation of treatment with DOSTINEX, patients should be cautious when performing tasks that require quick and accurate reactions.
Patients taking DOSTINEX who experience sleepiness and/or sudden sleep attacks should not drive or operate machinery that may put themselves or others at risk of serious injury or death (e.g., when operating machinery) until sleepiness and/or sudden sleep attacks have resolved.

DOSTINEX contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take DOSTINEX

This medicine should always be taken exactly as prescribed by the doctor. If you have any doubts, consult your doctor or pharmacist.
DOSTINEX is intended for oral use. It is recommended to take DOSTINEX with meals.
In patients with intolerance to dopaminergic medicines, to reduce the likelihood of side effects, the doctor may decide to start treatment with a reduced dose of DOSTINEX (e.g., 0.25 mg once a week) and gradually increase the dose to the therapeutic dose.
In case of persistent or severe side effects, to improve tolerance to the medicine, the doctor may decide to temporarily reduce the dose and then return to the therapeutic dose by gradually increasing it (e.g., 0.25 mg weekly, every two weeks).
Inhibition of lactation
The recommended dose is: 1 mg of cabergoline (2 tablets of 0.5 mg) on the first day after childbirth.
Stopping milk production
The recommended dose is: 0.25 mg (half a tablet) every 12 hours for two days.
Treatment of disorders associated with excessive prolactin secretion
The recommended initial dose is 0.5 mg per week, administered in one (1 tablet of 0.5 mg) or two doses (2 times a week, half a tablet).
The weekly dose should be increased gradually, preferably by 0.5 mg per week at monthly intervals, until optimal therapeutic effect is achieved. The therapeutic dose ranges from 0.25 mg to 2 mg per week, with an average of 1 mg per week. In patients with hyperprolactinemia, doses up to 4.5 mg per week have been used.
The doctor will decide on the appropriate administration of the weekly dose: once or in two or more portions, depending on the patient's tolerance to the medicine.
The doctor will determine the smallest effective dose that achieves the therapeutic effect. After determining the therapeutic dose, the doctor will decide on the appropriate control of prolactin levels in the blood.
Normalization of prolactin levels is usually achieved within 2-4 weeks.
After completion of treatment with DOSTINEX, a relapse of hyperprolactinemia is usually observed. However, in some patients, a persistent decrease in prolactin levels has been observed for several months. In most women, ovulatory cycles occurred for at least 6 months after completion of treatment.

Use in children and adolescents

The safety and efficacy of DOSTINEX in patients under 16 years of age have not been evaluated.

Use in patients with liver function disorders

In patients with severe liver dysfunction, a reduced dose of DOSTINEX should be considered (see section: When to be cautious when taking DOSTINEX).

Use in elderly patients

No regular studies have been conducted on the use of DOSTINEX in elderly patients with disorders associated with excessive prolactin secretion.

Use of a higher than recommended dose of DOSTINEX

In case of overdose, contact your doctor. The symptoms of overdose are likely to be those associated with excessive stimulation of dopamine receptors, such as nausea, vomiting, gastrointestinal disorders, orthostatic hypotension, confusion, and/or psychosis or hallucinations.
If necessary, the doctor will use supportive methods to remove the unabsorbed medicine and stabilize blood pressure values. Additionally, the doctor may use treatment with dopamine antagonists.

Missing a dose of DOSTINEX

If the patient forgets to take DOSTINEX, they should take it as soon as possible, unless it is almost time for the next dose. In this case, the next dose should be taken at the scheduled time. Do not take a double dose to make up for the missed dose.

Stopping treatment with DOSTINEX

The decision to stop treatment is made by the doctor.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, DOSTINEX can cause side effects, although not everybody gets them.
Side effects observed during treatment with DOSTINEX to inhibit lactation:
Side effects have been ranked according to frequency. They reflect the data from clinical trials with DOSTINEX administered at a dose of 1 mg and in breastfeeding women who received DOSTINEX at a dose of 0.25 mg every 12 hours to inhibit lactation.
Reported side effects were mostly transient, with mild to moderate severity.
During the first 3-4 days after childbirth, asymptomatic decreases in blood pressure (≥20 mmHg systolic and ≥10 mmHg diastolic) may occur.
Side effects observed during treatment with DOSTINEX for disorders associated with excessive prolactin secretion:
Side effects have been ranked according to frequency. They reflect the data from 6-month clinical trials with DOSTINEX administered at a dose of 1-2 mg per week (administered in two doses per week). Reported side effects were mostly mild to moderate and occurred mainly in the first two weeks of treatment. Most of them resolved during treatment or within a few days after discontinuation of the medicine.
General information:
Side effects depend mainly on the dose.
DOSTINEX may cause a decrease in blood pressure when used for a long time, although orthostatic hypotension or fainting is rare.
DOSTINEX is an ergot derivative, so it may have a vasoconstrictive effect. With long-term use, abnormal results of standard laboratory tests are unlikely; in non-menstruating women, a decrease in hemoglobin has been observed during the first few months after resumption of menstruation.
The following side effects may occur:

• inability to resist an impulse, temptation, or compulsion to perform actions that may be harmful to the patient or others; this includes: - strong impulse or uncontrolled gambling, despite serious personal or family consequences, - changed or increased sexual interests and behaviors of great importance to the patient or others, e.g., activities related to increased sexual drive,

compulsive, uncontrolled spending or buying,
episodes of binge eating (consuming larger amounts of food than normal and more than needed to satisfy hunger).
Tell your doctor if you experience any of these behaviors to discuss ways to control or limit these symptoms.
Side effects have been ranked according to frequency.

Very common (more than 1 in 10 people)

• valvular heart disease (including valve regurgitation) and associated conditions (pericarditis, pericardial effusion)
• headache *, dizziness of central and/or peripheral origin *
• nausea *, dyspepsia, gastritis *, abdominal pain *
• fatigue *** , tiredness

Common (more than 1 in 100, but less than 1 in 10 people)

• drowsiness
• depression
• decreased blood pressure in patients undergoing long-term treatment; orthostatic hypotension, hot flashes **
• constipation, vomiting **
• chest pain
• asymptomatic decreases in blood pressure (systolic ≥20 mmHg and diastolic ≥10 mmHg)

Uncommon (more than 1 in 1,000, but less than 1 in 100 people)

• palpitations
• dyspnea, pleural effusion, fibrosis (including pulmonary fibrosis), epistaxis
• hypersensitivity reactions
• transient hemianopia, syncope, paresthesia
• increased libido
• digital vasospasm
• edema, peripheral edema
• rash, alopecia
• leg cramps
• in non-menstruating women, a decrease in hemoglobin has been observed during the first few months after resumption of menstruation

Rare (more than 1 in 10,000, but less than 1 in 1,000 people)

• epigastric pain

Very rare (less than 1 in 10,000 people)

• pleural fibrosis

Unknown: frequency cannot be estimated from available data

• angina pectoris
• respiratory disorders, respiratory failure, pleuritis, chest pain
• sudden sleep attacks, tremors
• visual disturbances
• liver function disorders
• increased creatine phosphokinase levels in the blood, abnormal liver function test results *Very common in patients treated for hyperprolactinemia; Common in patients treated to inhibit lactation

**Common in patients treated for hyperprolactinemia; Uncommon in patients treated to inhibit lactation
***Very common in patients treated for hyperprolactinemia; Very common in patients treated to inhibit lactation

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or parallel importer.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store DOSTINEX

Store in a temperature below 25°C.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What DOSTINEX contains

• The active substance of DOSTINEX is cabergoline. One tablet contains 0.5 mg of cabergoline.
• The other ingredients are: leucine, anhydrous lactose.

What DOSTINEX looks like and contents of the pack

DOSTINEX is a white, capsule-shaped tablet with a score line, 4 x 8 mm in size.
The tablet can be divided into equal doses.
The tablets are packed in a glass bottle, type I, with a desiccant-containing closure or in an HDPE bottle with a PP child-resistant closure containing a desiccant, in a cardboard box.
The pack contains 2 or 8 tablets.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Spain, the country of export:

Pfizer, S.L., Avda. De Europa, 20-B, Business Park La Moraleja, 28108 Alcobendas (Madrid), Spain

Manufacturer:

Pfizer Italia S.r.L., Località Marino del Tronto – 63100, Ascoli Piceno (AP), Italy

Parallel importer:

PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna

Repackaged by:

Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw
IVA Pharm Sp. z o.o., ul. Drawska 14/1, 02-202 Warsaw
LABOR Przedsiębiorstwo Farmaceutyczno-Chemiczne Sp. z o.o., ul. Długosza 49, 51-162 Wrocław
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
CANPOLAND SPÓŁKA AKCYJNA, ul. Beskidzka 190, 91-610 Łódź
Authorization number in Spain, the country of export:683052.9

• 683045.1
• 710401.8
• 710402.5

Parallel import authorization number:110/17
Date of leaflet approval: 30.03.2022
[Information about the trademark]